(30 days)
No reference devices were used in this submission.
No
The description focuses on the mechanical and electrical aspects of the device, its energy delivery mechanism, and its intended use for surgical ablation. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is intended to ablate cardiac tissue and create lesions in the heart, which is a therapeutic intervention.
No
The device is an ablation device used to ablate cardiac tissue during surgery, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines a physical, handheld surgical ablation device with electrodes, a saline irrigation system, and a mechanical locking mechanism. It is designed to deliver radiofrequency energy generated by an external hardware generator. This is a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body.
- Device Function: The Cardioblate Gemini Surgical Ablation Device is used during cardiac surgery to ablate (destroy) cardiac tissue using radiofrequency energy. It is a surgical tool used directly on the patient's heart.
- Intended Use: The intended use clearly states it is for "ablating cardiac tissue during cardiac surgery." This is an in-vivo (within the living body) procedure, not an in-vitro (in glass/outside the body) diagnostic test.
The device is a surgical instrument used for treatment, not for diagnosing a condition by analyzing a sample.
N/A
Intended Use / Indications for Use
The Cardioblate™ Gemini™ Surgical Ablation Device is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy. The system is indicated for use, under direct or endoscopic visualization, in surgical procedures, including minimally invasive surgical procedures.
Product codes
OCL
Device Description
The Cardioblate Gemini surgical ablation device (Model 49351), figure 1 below, is a handheld, single-use, bipolar, radio-frequency (RF) ablation device for use in cardiac surgery. It has a saline irrigation system to deliver fluid at the contact point between the tissue and electrode to cool the tissue during RF energy delivery. This device is intended for intermittent operation
Model 49260 of the Cardioblate Gemini surgical ablation device is intended for use with Cardioblate 68000 Generator (figure 2), whereas Model 49351 is intended for use with the Valleylab™ FT10 Energy(figure 3), whereas model 49260 is intended for use with Cardioblate 68000 Generator(figure 3). The devices are provided sterile and nonpyrogenic, are disposable, and are for single use only. They are sterilized using ethylene oxide.
The Cardioblate Gemini-s is a bipolar electrode device that transmits radio frequency energy, generated by an external generator, between the two electrodes. The device has dual linear electrodes, 6.3 cm in length, with integral fluid delivery to the electrodes. The Gemini-s device is port accessible, intended for open or closed chest procedures to ablate tissue through resistive heating due to radiofrequency energy passing through tissue. The device is designed to reproduce the Cox-Maze lesion pattern by creating linear transmural lesions in both atria of the heart during cardiac procedures.
The Gemini-s surgical ablation device has a flexible neck design that provides the physician with the ability to access various anatomies utilizing a neck curve through the full range from 0 to 180-degree configuration.
Once the electrodes are correctly positioned, the parallel jaws lock by squeezing the handle. The electrodes have full contact with the tissue and the locking mechanism must be fully engaged to ensure accurate transmurality readings. Simultaneous with the actuation of the trigger and jaw closure is the opening of the (normally closed) fluid path to start the flow of saline. The device automatically shuts off the saline when the jaws are open and when the device is not in use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiac tissue, heart
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The modifications described in this Special 510(k) Notification were verified through design verification testing. The Design Failure Modes and Effects Analysis (DFMECA) file was updated along with the Risk Management File to reflect the current status and risk evaluations at the device and system level. Risk Assessment concluded that no new biocompatibility testing was needed for the proposed Cardioblate Gemini Surgical Ablation Devices because there are no changes to:
- Intended use
- Technological characteristics
- Operating principle
- Design features
- Device and packaging materials
- Sterilization requirements
- Shelf life
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 22, 2022
Medtronic Inc. Rajitha Nair Sr. Regulatory Affairs Specialist 7611 Northland Drive Minneapolis, Minnesota 55448
Re: K223508
Trade/Device Name: Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation Device Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: OCL Dated: November 21, 2022 Received: November 22, 2022
Dear Rajitha Nair:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Aneesh S. Deoras -S
Aneesh Deoras Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223508
Device Name
Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation Device
Indications for Use (Describe)
The Cardioblate™ Gemini™ Surgical Ablation Device is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy. The system is indicated for use, under direct or endoscopic visualization, in surgical procedures, including minimally invasive surgical procedures.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
K223508 510(k) Summary Complying with 21 CFR 807.92
510(k) Summary
Submitter
| Date Prepared: | November 21, 2022 |
|---|---|
| Applicant: | Medtronic, Inc. |
| Medtronic Perfusion Systems | |
| 7611 Northland Drive | |
| Minneapolis, MN 55428 | |
| Establishment Registration Number: 2184009 | |
| Contact Person: | Rajitha Nair |
| Senior Regulatory Affairs Specialist | |
| Medtronic Perfusion Systems | |
| Phone: 609-760-1907 | |
| Email: rajitha.nair@medtronic.com | |
| Alternate Contact: | Megan Schlichting |
| Regulatory Affairs Manager | |
| Medtronic Perfusion Systems | |
| Phone: 763-526-3087 |
Device
| Trade Name | Common
Name | Classification
Name | Classification | Classification
Panel | Regulation | Product
Code |
|-----------------------------------------------------------------|----------------------------|----------------------------------------------------------------------------|----------------|-------------------------|--------------------|-----------------|
| Cardioblate
Gemini-s 49260
Surgical
Ablation
Device | Electrosurgic
al device | Electrosurgical
cutting and
coagulation
device and
accessories | Class II | Cardiovascular | 21 CFR
878.4400 | OCL |
| Cardioblate
Gemini-s 49351
Surgical
Ablation
Device | Electrosurgic
al device | Electrosurgical
cutting and
coagulation
device and
accessories | Class II | Cardiovascular | 21 CFR
878.4400 | OCL |
Email: megan.schlichting@medtronic.com
Predicate Device
| Trade Name | 510(k) | Clearance Date |
|---|---|---|
| Cardioblate Gemini-s 49260 Surgical Ablation Device | K121767 | 7/13/2012 |
| Cardioblate Gemini-s 49351 Surgical Ablation Device | K200514 | 6/3/2020 |
No reference devices were used in this submission.
4
K223508 510(k) Summary Complying with 21 CFR 807.92
Device Description
The Cardioblate Gemini surgical ablation device (Model 49351), figure 1 below, is a handheld, single-use, bipolar, radio-frequency (RF) ablation device for use in cardiac surgery. It has a saline irrigation system to deliver fluid at the contact point between the tissue and electrode to cool the tissue during RF energy delivery. This device is intended for intermittent operation
Model 49260 of the Cardioblate Gemini surgical ablation device is intended for use with Cardioblate 68000 Generator (figure 2), whereas Model 49351 is intended for use with the Valleylab™ FT10 Energy(figure 3), whereas model 49260 is intended for use with Cardioblate 68000 Generator(figure 3). The devices are provided sterile and nonpyrogenic, are disposable, and are for single use only. They are sterilized using ethylene oxide.
The Cardioblate Gemini-s is a bipolar electrode device that transmits radio frequency energy, generated by an external generator, between the two electrodes. The device has dual linear electrodes, 6.3 cm in length, with integral fluid delivery to the electrodes. The Gemini-s device is port accessible, intended for open or closed chest procedures to ablate tissue through resistive heating due to radiofrequency energy passing through tissue. The device is designed to reproduce the Cox-Maze lesion pattern by creating linear transmural lesions in both atria of the heart during cardiac procedures.
The Gemini-s surgical ablation device has a flexible neck design that provides the physician with the ability to access various anatomies utilizing a neck curve through the full range from 0 to 180-degree configuration.
Once the electrodes are correctly positioned, the parallel jaws lock by squeezing the handle. The electrodes have full contact with the tissue and the locking mechanism must be fully engaged to ensure accurate transmurality readings. Simultaneous with the actuation of the trigger and jaw closure is the opening of the (normally closed) fluid path to start the flow of saline. The device automatically shuts off the saline when the jaws are open and when the device is not in use.
Image /page/4/Picture/7 description: The image shows a Medtronic surgical tool. The tool has a gray and blue handle with a trigger and a long, black, flexible shaft. At the end of the shaft are two small, curved metal prongs.
Figure 1: Cardioblate Gemini-s (Model 49260, 49351)
5
Image /page/5/Picture/1 description: The image shows a portable medical device, possibly a defibrillator or similar diagnostic tool. It features a screen that is flipped open, revealing a user interface with buttons and possibly a display area. The device is primarily white with blue accents, and it has a handle for easy carrying.
Figure 2 Cardioblate 68000 Generator Medtronic VLFT10GEN Generator
| Acres problem of | |
|---|---|
| DON . |
Image /page/5/Figure/4 description: This image is a title for a figure. The title says "Figure 3: Medtronic VLFT10GEN Generator". The title is written in a bold, sans-serif font. The title is centered on the image.
Principles of Operation
The device applies endocardial radiofrequency energy. The energy platform monitors tissue impedance and adjusts the amount of power delivered to the tissue between the active electrodes to create transmural lesions in the intracardiac tissue. Irrigated Radiofrequency Frequency (RF) ablation uses medium frequency alternating current to generate heat, which destroys abnormal electrical conduction pathways while cooling the cardiac tissue. Radiofrequency (RF) ablation is a procedure where medium frequency (434 KHz ± 10%) energy is delivered into cardiac tissue. The radiofrequency energy is delivered from a generator, through the irrigated electrode (patient contacting end of handheld device) and into the tissue. When the energy encounters the higher impedance of cardiac tissue, heat is produced, causing cells to die. As tissue temperature rises above 113° F (50° C), protein is permanently damaged and cell membranes fuse causing irreversible cardiac cell death. Once the cells are no longer viable, they are unable to propagate electrical signals. This type of electrical energy has been used in medical procedures for decades.
Indications for Use
The Cardioblate® Gemini® Surgical Ablation Device is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy. The system is indicated for use, under direct or endoscopic visualization, in surgical procedures, including minimally invasive surgical procedures.
Comparison of Technological Characteristics with the Predicate Device
When compared to the predicate devices, the Cardioblate Gemini Surgical Ablation Devices presented in this submission have the same:
- intended use/indications for use
- contraindications
- operating principle
- energy type
6
K223508
510(k) Summary Complying with 21 CFR 807.92
- mechanism of action
- . radiofrequency generator and delivery system
- . patient contacting materials
- shelf life
- sterilization process
- dimensions
- performance
- irrigation
- Electrical
- packaging configuration and materials
When compared to the predicate devices, the Cardioblate Gemini Surgical Ablation Devices presented in this submission have the following differences:
- . IFU updates (new warning and updated directions for use)
Performance Data
The modifications described in this Special 510(k) Notification were verified through design verification testing. The Design Failure Modes and Effects Analysis (DFMECA) file was updated along with the Risk Management File to reflect the current status and risk evaluations at the device and system level. Risk Assessment concluded that no new biocompatibility testing was needed for the proposed Cardioblate Gemini Surgical Ablation Devices because there are no changes to:
- Intended use
- Technological characteristics
- Operating principle
- Design features
- Device and packaging materials
- Sterilization requirements
- Shelf life
Conclusions
The Predicate devices are legally marketed under K121767 (49260) and K200514 (49351), have the same intended use, and the same technological and performance characteristics as the subject devices. The proposed change to the IFU adds a new warning to align with the DFMECA. Additionally, directions for use have been updated to provide additional clarity and minimize use error. These changes do not arise from different technological characteristics of the devices or raise different questions of safety and effectiveness.
In summary, this submission demonstrates that the Cardioblate Gemini Ablation Devices are substantially equivalent2 to the legally marketed predicate devices.
- The term 'substantially equivalent' as used herein is intended to be a determination of substantial equivalency under the Federal Food, Drug, and Cosmetic Act and relates to the fact the product can be marketed without premarket approval or reclassification. Such a determination is not intended to have any bearing whatsoever on the resolution of patent infringement suits or other patent matters." (Federal Register, Vol. 42, No. 163, Aug. 23, 1977, page 42525 and 42529).